Article R1161-20
Any change to any of the elements of the application for authorisation of the programme will give rise to a new authorisation, issued under the same conditions as the initial authorisation.
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Showing 5441–5450 of 56936 articles for “Art. I-3°”
Any change to any of the elements of the application for authorisation of the programme will give rise to a new authorisation, issued under the same conditions as the initial authorisation.
I. - The Director General of the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) decides on the application…
The authorisation is issued for a period of three years and may be renewed for an identical period on application by the authorisation holder to the Director General of the Agence nationale de sécurit…
Decisions to authorise or withdraw authorisation taken in application of Article L. 1161-5 are published on the Agency's website. Decisions to withdraw programme authorisation may be accompanied by an…
The application is accompanied by a dossier comprising: 1° The summary of product characteristics and the package leaflet; 2° The name and address of the registered office of the chosen operator; 3° A…
The application for authorisation referred to in Article L. 1161-5 is sent by the company exploiting the medicinal product to the Director General of the Agence nationale de sécurité du médicament et…
The withdrawal or suspension of the authorisation is issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. The company exploiting the medicinal pro…
En application de l'article LO 6371-5, une dotation globale de fonctionnement est instituée afin de contribuer à compenser les accroissements nets de charges de la collectivité de Saint-Martin résulta…
I.-The support institution designated by the constituent agreement performs the following functions on behalf of the institutions that are members of the consortium:1° The strategy, optimisation and j…
Where a concession contract covers several activities, at least one of which constitutes a network operator activity, and whose main purpose can be determined, the following rules apply: 1° Where the…
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